Trial results for a pilot study on group visits for high-risk Type 1 Diabetes (T1D) were posted on ClinicalTrials.gov on 2025-12-22, with 14 participants enrolled.
Background
Type 1 Diabetes (T1D) is a chronic autoimmune condition requiring lifelong insulin management. For underserved youth with poorly controlled T1D, achieving optimal glycemic control and self-management can be particularly challenging. Shared medical appointments (SMAs) offer a model of care delivery that aims to provide comprehensive support and education in a group setting, potentially improving outcomes and addressing the complex needs of this population. This pilot study aimed to assess the feasibility and acceptability of SMA visits and their impact on glycemic control, self-management skills, and health-related quality of life in this specific demographic.
Trial design
This completed pilot prospective cohort study, designated as Phase NA, enrolled 14 participants with Type 1 Diabetes. The trial investigated the impact of shared medical appointments (SMAs) in underserved youth with poorly controlled T1D. Participants attended SMA visits every 3 months over a 12-month study period, followed by a 6-month observational period. The study aimed to assess the feasibility and acceptability of SMA and its impact on glycemic control, self-management skills, and health-related quality of life.
Key results
The trial reported several key measurements related to the feasibility and outcomes of the SMA intervention:
- Percentage of Eligible Participants Who Agreed to Participate: 14 Participants in the SMA Visit Intervention Arm.
- Frequency of SMA Sessions Attended: A median of 90% of visits attended was observed in the SMA Visit Intervention Arm.
- Percentage of Participants With CGM Use: A median of 87.5% of 14-day CGM wear was observed in the SMA Visit Intervention Arm.
- Perceived Satisfaction of SMA Intervention: 2 Participants were assessed in the SMA Visit Intervention Arm.
- Percentage of Time in Range (70-180 mg/dl):
- Mean of 27.25% (Standard Deviation 1.71)
- Mean of 21.75% (Standard Deviation 10.56)
- Mean of 23.67% (Standard Deviation 3.79)
- Mean of 29.00% (Standard Deviation 5.66)
- Mean of 33.33% (Standard Deviation 8.33)
- Mean of 38.00% (Standard Deviation 3.61)
- Mean of 27.00% (Standard Deviation 9.17)
- Continuous Glucose Monitor Time Below Range (<70 mg/dL): A mean of 2.45% (Standard Deviation 1.73) of time below range was observed.
What this means
The posted results from this pilot study provide initial insights into the feasibility and participant engagement with shared medical appointments (SMAs) for underserved youth with Type 1 Diabetes. High rates of SMA session attendance and CGM use suggest that this intervention model is acceptable and feasible for this population. While various mean percentages for Time in Range (70-180 mg/dl) and Time Below Range (<70 mg/dL) were reported, the small sample size of 14 participants and the pilot nature of the study mean these glycemic control measurements should be interpreted as preliminary. These findings support the potential for SMAs to improve engagement in care and self-management behaviors, warranting further investigation in larger, controlled studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05431686, titled "Group Visits for High Risk Type 1 Diabetes (T1D)", were posted on 2025-12-22 on clinicaltrials.gov.